Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-2353

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

e5a2e520-4bfe-49c5-b4d6-c4c78b343d7a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Package DI Number

40612479203608

Quantity per Package

24

Contains DI Package

10612479203591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case